(154 days)
Not Found
No
The document describes standard signal processing for blood pressure and pulse rate, and mentions "software" for analysis, but does not use terms like AI, ML, DNN, or describe training/test sets which are typical indicators of AI/ML.
No
The device is a digital monitor for measuring blood pressure and pulse rate, providing information rather than directly treating or preventing a disease or condition. While it detects irregular heartbeats, this is a warning signal and not a therapeutic intervention.
No
The device is described as a digital monitor for measuring blood pressure and pulse rate. While it detects irregular heartbeats, it explicitly states it "gives a warning signal with readings," rather than analyzing or diagnosing the irregular heartbeats. The primary function listed is measurement, not diagnosis.
No
The device description explicitly mentions hardware components such as a battery, AC adaptor, integral pump, electronically controllable valve, and a Bluetooth module, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures blood pressure and pulse rate by applying a cuff to the arm and analyzing pressure changes. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be powered from an IEC 60601-1 compliant AC adaptor. The device inflates a cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During deflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure.
The device is intended to be used with Omron specified cuffs as specified below
- Small 17-22cm arm cuff - circumference (PN: HEM-CS24)
- Medium 22-42cm arm cuff circumference (PN: HEM-RML31) ●
- . Extra Large (XL) cuff arm circumference 42-50cm (PN: HEM-RXL31)
The device also detects the appearance of irregular heartbeats during measurement.
The device can also send measurement data to third party applications. Transmission is via an integral FCC compliant Bluetooth Low Energy (BLE) module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
Adult patient population.
Intended User / Care Setting
Home user
Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing
Bench tests were performed and found that the HEM-9210T met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate. Testing includes:
- Verification Testing
- Testing for compliance to AAMI ES 60601-1
- Testing for compliance to IEC 60601-1-2
- Testing for compliance to IEC 60601-1-11
- Testing for compliance to IEC 80601-2-30
- Comparative Testing to the predicate
The results demonstrate that the devices perform as intended are substantially equivalent to the performance of the predicate and in accordance with applicable standards.
Biocompatibility of Materials
The patient contacting materials of the cuff have been tested in accordance with ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation. ISO 10993-1 considered the patient contacting as Surface, Skin, Limited duration of use.
Human Factors / Usability
Usability testing was performed with 18 lay users. There were no failures, user errors or near misses.
Clinical Testing Summary
Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2. This testing was performed on 92 patients with results showing compliance to the standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Omron HEM-7311 K133379
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2017
Omron Healthcare, Inc. % Paul Dryden, Consultant Promedic. LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K163235
Trade/Device Name: HEM-9210T Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 22, 2017 Received: March 23, 2017
Dear Paul Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Omron Healthcare HEM-9210T
Indications for Use (Describe)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Type of Use (Select one or both, as applicable)
]Prescription Use (Part 21 CFR 801 Subpart D)
|X|Over-The-Counter Use (21 CFR 801 Subpart C)
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PDF PAGE 36 of 867
3
| 510(k) Summary |
|---|
| Page 1 of 8 |
| 11/15/2016 |
| Omron Healthcare, Inc. | |
|---|---|
| 1925 West Field Court | |
| Lake Forest, IL 60045 USA | |
| Official Contact: | Renee Thornborough – Executive Director QA/RA |
| Proprietary or Trade Name: | Model HEM-9210T |
| Common/Usual Name: | Noninvasive blood pressure measurement system. |
| Classification Name/Code: | DXN – Noninvasive blood pressure measurement |
| system. | |
| 21CFR 870.1130 | |
| Class II | |
| Device: | Model HEM-9210T |
| Predicate Device: | Omron HEM-7311 K133379 |
Device Description:
The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be powered from an IEC 60601-1 compliant AC adaptor. The device inflates a cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During deflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure.
The device is intended to be used with Omron specified cuffs as specified below
- Small 17-22cm arm cuff - circumference (PN: HEM-CS24)
- Medium 22-42cm arm cuff circumference (PN: HEM-RML31) ●
- . Extra Large (XL) cuff arm circumference 42-50cm (PN: HEM-RXL31)
The device also detects the appearance of irregular heartbeats during measurement.
The device can also send measurement data to third party applications. Transmission is via an integral FCC compliant Bluetooth Low Energy (BLE) module.
Intended User
Home user
4
510(k) Summary Page 2 of 8 11/15/2016
Patient Population
This device is intended for use on adults.
Indications for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Environment of Use:
Home
Contraindications:
There are no known contraindications.
Predicate Device Comparison:
The HEM-9210T was compared to the predicate HEM-7311- K133379 in the device comparison table below.
5
K163235 Omron HEM-9210T
510(k) Summary Page 3 of 8 11/15/2016
Device Comparison
| Predicate Devices | New Device | Comparison | ||
|---|---|---|---|---|
| Model Name: | HEM-7311 | HEM-9210T | - | |
| 510(k) Number | K133379 | --- | - | |
| Indications | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. | |||
| The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. | |||
| The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. | Identical | |||
| Environmental of Use | Home | Home | Identical | |
| Patient Population | Adult | Adult | Identical |
Specifications / Features
| Specification | HEM-7311 | HEM-9210T | Comparison |
|---|---|---|---|
| Measurement method | Cuff oscillometric method | Cuff oscillometric method | Identical |
| Measurement range | Pressure: 0 to 299 mmHg | ||
| Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299 mmHg | ||
| Pulse Rate: 40 to 180 beats/min. | Identical | ||
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Identical |
| 510(k) Summary | |||
| Page 4 of 8 | |||
| 11/15/2016 | |||
| Specification | HEM-7311 | HEM-9210T | Comparison |
| Applicable cuff | |||
| (Arm Circumference) | 17-22cm (HEM-CS24) | ||
| 22-32cm (HEM-CR24) | |||
| 22-42cm (HEM-RML31) | 17-22cm (HEM-CS24) | ||
| Cleared under K133379 | |||
| 22-42cm (HEM-RML31) | |||
| Cleared under K133379 | Similar to predicate, | ||
| additional range clinically | |||
| validated. | |||
| 42-50cm (HEM-RXL31) | |||
| (New) | |||
| Accuracy of pressure indicator | Within ±3 mmHg or 2 % of reading | Within ±3 mmHg or 2 % of reading | Identical |
| Accuracy of pulse rate | Within ±5 % of reading | Within ±5 % of reading | Identical |
| Inflation method | Automatic by electric pump | Automatic by electric pump | Identical |
| Deflation method | Automatic pressure release valve | Automatic pressure release valve | Identical |
| Display | LCD digital display | LCD digital display | Identical |
| Power Source | 4"AA"batteries or AC adapter | 4"AA"batteries or AC adapter | Identical |
| Operating conditions | 10 to 40 °C | ||
| 15 to 90 %RH | 10 to 40 °C | ||
| 15 to 90 %RH | Identical | ||
| Storage conditions | -20 to 60 °C | ||
| 10 to 95 %RH | -20 to 60 °C | ||
| 10 to 95 %RH | Identical | ||
| Dimensions (mm) | 183 (W) × 230 (D) × 99 (H) mm | 107 (W) × 141 (D) × 79 (H) mm | Similar in size. Size is not a |
| factor in function of the | |||
| device | |||
| Weight | Approx. 640g ( 1 lbs6 5/8 oz) | ||
| (not including battery) | Approx. 290g (10oz) | ||
| (not including battery) | Similar weight. Weight is | ||
| not a factor in function of | |||
| the device | |||
| Irregular Heart beat Feature | Yes | Yes | Identical |
| Page 5 of 8 | |||
| 11/15/2016 | |||
| Specification | HEM-7311 | HEM-9210T | Comparison |
| Body movement detection | Yes | Yes | Identical |
| Hypertension indicator | Yes | No | This feature does not affect |
| fundamental BP | |||
| measurement function | |||
| Average of latest three measurements | Yes | No | This feature does not affect |
| fundamental BP | |||
| measurement function | |||
| Provides an average of 3 | |||
| measurements | Yes | No | This feature does not affect |
| fundamental BP | |||
| measurement function | |||
| Multiple Users | Yes (2) | No | This feature does not affect |
| fundamental BP | |||
| measurement function | |||
| Bluetooth | No | Yes | This feature does not affect |
| fundamental BP | |||
| measurement function | |||
| Power supply | Regulates power voltage regardless of | ||
| battery voltage. | Regulates power voltage regardless of | ||
| battery voltage. | Identical | ||
| Microprocessor | determines blood pressure and | ||
| pulse rate | |||
| controls the pump, the valve, and | |||
| the display | |||
| detects switch operations | |||
| stores measurement results | |||
| manages date and time | determines blood pressure and pulse | ||
| rate | |||
| controls the pump, the valve, and | |||
| the display | |||
| detects switch operations | |||
| stores measurement results | |||
| manages date and time | Identical | ||
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Identical |
| Specification | HEM-7311 | HEM-9210T | Comparison |
| Rapid exhaust valve / Deflation | |||
| Valve | Active electronic control valve that | ||
| performs cuff air bleeding and release | Active electronic control valve that | ||
| performs cuff air bleeding and release | Identical | ||
| Inflation source | DC rolling diaphragm pump | DC rolling diaphragm pump | Identical |
| Display | LCD (Liquid Crystal Display) displays; | ||
| current cuff pressure systolic blood pressure diastolic blood pressure pulse rate error messages measurement results in the | |||
| memory | LCD (Liquid Crystal Display) displays; | ||
| current cuff pressure systolic blood pressure diastolic blood pressure pulse rate error messages | Similar, no memory function | ||
| Controls | START/STOP Button Date/Time setting Button Up/Down Button User ID Selections Button | START/STOP Button | Simplified |
| Cuff (included with device) | Soft Cuff(HEM-RML31) 22-42cm | Soft Cuff(HEM-RML31) 22-42cm | Identical |
| Biocompatibility of materials | Surface contact | ||
| Skin | |||
| Limited duration of use |